Angina Pectoris

• FDA approval · 2016-11-30
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (TRUPHARMA LLC)

  FDA approved a supplemental application for metoprolol tartrate submitted by TRUPHARMA LLC. This action approves the supplemental filing for…

• FDA approval · 2016-11-25
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for metoprolol succinate, establishing a generic sustained-release formulation from Actavis Pharma, In…

• FDA approval · 2016-11-18
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  FDA approved a supplemental application for verapamil hydrochloride from Wilshire Pharmaceuticals, Inc., updating the existing NDA.

• FDA approval · 2016-11-18
  FDA Approved: DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Diltiazem hydrochloride extended-release from Oceanside Pharmaceuticals. The product is a calciu…

• FDA approval · 2016-11-18
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals Inc)

  FDA approved a supplemental application for Verapamil hydrochloride from Teva Pharmaceuticals Inc.

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• FDA approval · 2016-11-18
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (EXELA PHARMA SCIENCES, LLC)

  The FDA approved a supplemental application for verapamil hydrochloride from Exela Pharma Sciences, LLC.

• FDA approval · 2016-11-18
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved Oceanside Pharmaceuticals' supplemental application for diltiazem hydrochloride. The approval confirms a modification to the pr…

• FDA approval · 2016-11-18
  FDA Approved: CARDIZEM CD — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental application for Cardizem CD (diltiazem hydrochloride) submitted by Bausch Health US LLC.

• FDA approval · 2016-11-08
  FDA Approved: MATZIM LA — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for MATZIM LA, a diltiazem hydrochloride product from Actavis Pharma, Inc.

• FDA approval · 2016-09-23
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for nicardipine hydrochloride (Hikma Pharmaceuticals USA Inc.), resulting in labeling changes fo…

• FDA approval · 2016-09-02
  FDA Approved: NITROGLYCERIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Nitroglycerin submitted by Prasco Laboratories, granting regulatory approval for this produc…

• FDA approval · 2016-08-29
  FDA Approved: NITROSTAT — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Nitrostat (nitroglycerin) filed by Viatris Specialty LLC.

• FDA approval · 2016-08-26
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Cardene IV (nicardipine hydrochloride) from Baxter Healthcare Corporation, enabling an additiona…

• FDA approval · 2016-08-25
  FDA Approved: NIFEDIPINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approves Ingenus Pharmaceuticals' original application for a generic nifedipine product, enabling its marketing for hypertension and ang…

• FDA approval · 2016-08-22
  FDA Approved: NITROGLYCERIN IN DEXTROSE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for NITROGLYCERIN IN DEXTROSE by Baxter Healthcare Company, indicating regulatory approval and label…

• FDA approval · 2016-07-15
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for metoprolol succinate from BluePoint Laboratories, enabling continued marketing of this generic b…

• FDA approval · 2016-06-13
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for metoprolol succinate (generic) from Mylan Pharmaceuticals Inc., resulting in labeling changes as…

• FDA approval · 2016-03-21
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Lopressor (metoprolol tartrate) filed by Validus Pharmaceuticals LLC.

• FDA approval · 2016-01-28
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for amlodipine besylate from Cipla USA Inc.

• FDA approval · 2016-01-26
  FDA Approved: NIFEDIPINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for nifedipine from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. This action repres…

• FDA approval · 2016-01-08
  FDA Approved: NITROGLYCERIN TRANSDERMAL INFUSION SYSTEM — Supplemental Application (Dr. Reddy's Laboratories, Inc.)

  FDA approved a supplemental application for the Nitroglycerin Transdermal Infusion System from Dr. Reddy's Laboratories, Inc.

• FDA approval · 2015-12-21
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Inderal LA (propranolol hydrochloride) by ANI Pharmaceuticals, Inc., granting approval for chang…

• FDA approval · 2015-12-16
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for metoprolol succinate by Quallent Pharmaceuticals Health LLC, indicating approval of the suppleme…

• FDA approval · 2015-11-30
  FDA Approved: FELODIPINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Felodipine by Glenmark Pharmaceuticals Inc., updating the labeling. It confirms its use for hype…

• FDA approval · 2015-11-24
  FDA Approved: NIFEDIPINE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for nifedipine by Upsher-Smith Laboratories, LLC, facilitating a labeling/strength update for the ge…